The Role of Alcohol Consumption in the Aetiology of Different Cardiovascular Disease Phenotypes: a CALIBER Study

NCT01864031 | Unknown DMC

• 3 other identifiers: CALIBER 12-02086091/Z/08/ZRP-PG-0407-10314
• Study Type: observational
• Target: 2,240,000
• Locations: 1 country
• Sites: 1

Brief Summary

The association between alcohol consumption and cardiovascular disease (CVD) has mostly been examined using broad endpoints or cause-specific mortality. The purpose of our study is to compare the effect of alcohol consumption in the aetiology of a range of cardiovascular disease phenotypes.

Conditions

Chronic Stable Angina; Unstable Angina; Coronary Heart Disease Not Otherwise Specified; Acute Myocardial Infarction; Heart Failure; Ventricular Arrhythmias; Cardiac Arrest; Abdominal Aortic Aneurysm; Peripheral Arterial Disease; Ischaemic Stroke; Subarachnoid Haemorrhagic Stroke; Intracerebral Haemorrhagic Stroke; Stroke Not Otherwise Specified; Sudden Cardiac Death; Unheralded Coronary Death; Mortality; Coronary Heart Disease (CHD); Cardiovascular Disease (CVD); Fatal Cardiovascular Disease (Fatal CVD); ST Elevation Myocardial Infarction (STEMI); Non-ST Elevation Myocardial Infarction (nSTEMI); Myocardial Infarction Not Otherwise Specified (MI NOS)

Keywords

Alcohol; Drinking; Abstainers; Former drinkers; Ex-drinkers; Aetiology; Initial presentation; Chronic Stable Angina; Unstable Angina; Coronary Heart Disease Not Otherwise Specified; Acute Myocardial Infarction; Heart Failure; ST elevation Myocardial Infarction (STEMI); non-ST elevation Myocardial Infarction (nSTEMI); Myocardial Infarction Not Otherwise Specified (MI NOS); Ventricular Arrhythmias; Cardiac Arrest; Abdominal Aortic Aneurysm; Peripheral Arterial Disease; Ischaemic Stroke; Subarachnoid Haemorrhagic Stroke; Intracerebral haemorrhagic Stroke; Stroke Not Otherwise Specified; Sudden Cardiac Death; Unheralded Coronary Death; Mortality; Coronary Heart Disease (CHD); Cardiovascular Disease (CVD); Fatal Cardiovascular Disease (fatal CVD)

Outcome Measures

Primary Outcomes (1)

• Initial presentation of cardiovascular disease

  See "Conditions" and "Detailed Description" sections for further description of the endpoints used.

  Study follow-up will commence on the earliest date that a patient fulfils the study inclusion criteria during the period between 1st January 1997 and 25th March 2010 (maximum of 13 years follow-up)

Secondary Outcomes (1)

• Non-CVD mortality

  Same as for primary outcomes (maximum of 13 years follow-up)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort used in the present study was drawn from patients registered with GPRD general practices in England that consented to data linkage (approx. 5% of the UK population). We used an open cohort design, where participants joined the cohort when they met the inclusion criteria at any point between 1st January 1997 and 25th March 2010 (the last GPRD data submission). Patients were included in cohort if they were aged ≥ 30 years, had at least one year of electronic health record data which met GPRD data quality standards, and had no record indicating any cardiovascular disease prior to study entry. Patients were followed up until the date of an initial presentation of one of our cardiovascular endpoints or were censored on the date of leaving the practice/last data submission from their practice. Patients who died before 1st January 2001 were excluded as cause-specific mortality data was not available for them (this approach is adopted in the Prospective Studies Collaboration).

You may qualify if:

• Aged ≥ 30 years.
• Patient in a GPRD registered practice that has consented to the linkage process (who also met data quality standards).

You may not qualify if:

• A recorded history of any cardiovascular disease phenotype prior to entering the study.
• Cause of death unknown.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, United Kingdom

Location

Related Publications (6)

• Ronksley PE, Brien SE, Turner BJ, Mukamal KJ, Ghali WA. Association of alcohol consumption with selected cardiovascular disease outcomes: a systematic review and meta-analysis. BMJ. 2011 Feb 22;342:d671. doi: 10.1136/bmj.d671.

  PMID: 21343207 BACKGROUND

• Roerecke M, Rehm J. The cardioprotective association of average alcohol consumption and ischaemic heart disease: a systematic review and meta-analysis. Addiction. 2012 Jul;107(7):1246-60. doi: 10.1111/j.1360-0443.2012.03780.x. Epub 2012 Mar 21.

  PMID: 22229788 BACKGROUND

• Mukamal K. Alcohol intake and noncoronary cardiovascular diseases. Ann Epidemiol. 2007 May;17(5 Suppl):S8-S12. doi: 10.1016/j.annepidem.2007.01.003.

  PMID: 17478332 BACKGROUND

• Stockwell T, Greer A, Fillmore K, Chikritzhs T, Zeisser C. How good is the science? BMJ. 2012 Mar 27;344:e2276; author reply e2294. doi: 10.1136/bmj.e2276. No abstract available.

  PMID: 22453883 BACKGROUND

• Denaxas SC, George J, Herrett E, Shah AD, Kalra D, Hingorani AD, Kivimaki M, Timmis AD, Smeeth L, Hemingway H. Data resource profile: cardiovascular disease research using linked bespoke studies and electronic health records (CALIBER). Int J Epidemiol. 2012 Dec;41(6):1625-38. doi: 10.1093/ije/dys188. Epub 2012 Dec 5.

  PMID: 23220717 BACKGROUND

• Bell S, Daskalopoulou M, Rapsomaniki E, George J, Britton A, Bobak M, Casas JP, Dale CE, Denaxas S, Shah AD, Hemingway H. Association between clinically recorded alcohol consumption and initial presentation of 12 cardiovascular diseases: population based cohort study using linked health records. BMJ. 2017 Mar 22;356:j909. doi: 10.1136/bmj.j909.

  PMID: 28331015 DERIVED

Related Links

• CALIBER project website
• UCL Research Department of Epidemiology and Public Health

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Heart Failure; Heart Arrest; Aortic Aneurysm, Abdominal; Peripheral Arterial Disease; Ischemic Stroke; Death, Sudden, Cardiac; Coronary Disease; Cardiovascular Diseases; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aortic Aneurysm; Aneurysm; Aortic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Death, Sudden; Death; Pathologic Processes; Myocardial Infarction; Infarction; Ischemia; Necrosis

Study Officials

• Steven Bell, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

• Harry Hemingway, FRCP

  University College, London

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Epidemiology

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 29, 2013
• Study Start: January 1, 1997
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

GB (1)